METHODS and DEVICES for SKIN CLOSURE

ABSTRACT

A wound closure device and a method of its use are disclosed. The wound closure device comprises a wound closure strip, the wound closure strip comprising a wound-facing side and a top side, the wound-facing side comprises an adhesive applied over at least a portion of the wound facing side of the wound closure strip and a non-symmetric, two-part release liner assembly detachably adhered to the adhesive, the release liner assembly comprising a first section and a second section with the second section comprising a wound closure strip-free portion forming a tab. In an alternate embodiment, the device is multi-segmented and the wound closure strip may be coextensive with the release liner assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims the benefit of U.S.patent application Ser. No. 16/907,930, filed Jun. 22, 2020, which is acontinuation of and claims the benefit of U.S. patent application Ser.No. 15/675,159, filed Aug. 11, 2027, now U.S. Pat. No. 10,687,986, whichis a continuation-in-part and claims the benefit of U.S. patentapplication Ser. No. 15/280,303, filed Sep. 29, 2016, now U.S. Pat. No.10,470,934. The complete disclosures of the aforementioned related U.S.patent application is hereby incorporated herein by reference for allpurposes.

BACKGROUND OF THE INVENTION Field of the Invention

This invention is concerned with devices, systems and methods for woundclosure, particularly for skin closure of wounds formed by lacerationsor surgical incisions.

Related Art

Wound closure tapes and topical adhesives provide an alternative towound closure by staples and sutures. Among the advantages of usingwound closure tapes or topical adhesives, and their combinations includeless tissue trauma, improved cosmetic outcomes, and less pain comparedwith staples and sutures when treating skin closures.

US 2002/0193721 discloses a wound closure grip-like tape apparatus andmethods of its use. Reference to FIG. 10 of US 2002/0193721 and thecorresponding text of this publication shows how the grip tape is usedto secure the wound of FIG. 9 . In particular, paragraph 43 of thepublication describes three techniques of wound closure reproduced inpart as follows: “The first exemplary means of sealing the wound is toplace WCGT (“Wound Closure Grid Tape”) 100 on one side of the wound 90with a slight bend along the axis between numbers 92 and 93 such thatthe other side 91 is tilted above the skin and thus will not adhere.With side 90 pressed in place and with the appropriate pressure applied,the WCGT is tugged with one hand while the other hand (or the thumb ofthe hand if being self-applied or with one hand) pushes the skin on theother side 91 into position, and then the WCGT is lowered into place.This handling can be done by grasping the WCGT at the edges wheredenigration of the adhesive is not as critical, or alternately byleaving the backing attached to the secondary side 91 while the firstside is pressed into place 90. The second exemplary means to apply is tocurve the WCGT upwards, or hold it in a curved position upwards alongthe longer axis shown, and position it starting at one end of the wound92. Then, as previously, the wound is pressed together and the WCGT ispressed into place gradually along the length of the wound, going fromone end 92 to the other 93. For small wounds, a third approach is tohold the WCGT by the edges and close the wound via pressures outside ofthe expected WCGT area, and then press the WCGT in place all at once.”

In the forgoing description, denigration of the wound-contactingadhesive is a recognized problem since holding at least some of theunderside of WCGT 100 is required particularly when side 90 of the woundis drawn toward side 91 of the wound. Thus, from the forgoingdescription, it appears that wound closure tape only to has a singlerelease liner.

US 2008/0302487 A1 describes a dispensing device configured to operatewith an adhesive backed mesh and backing film for tissue bonding. Thedevice prevents or eliminates distortion of the mesh prior toapplication to the wound sites and includes means for reducing oreliminating binding during use. The dispensing device is configured tooperate in a “forward” mode (substrate to which mesh is applied passesbeneath applicator after mesh is applied) to provide essentially anunobstructed view of the wound site during use. The backing film is asingle strip that protects denigration of adhesive and self adherence ofthe coiled adhesive-backed mesh.

US 2005/0182443 A is directed to a tissue bonding article which includesa flexible material, an adhesive substance applied over at least aportion of a bottom side of the flexible material, and a polymerizableadhesive composition permeated throughout at least a portion of theflexible material. Although not specifically shown in the figures, asuitable backing or release material may also be used to cover theadhesive substances applied to the bottom side of the flexible material.Such backing materials are well known in the art for covering adhesivesand can include, for example, paper, plastic, or the like.

There continues to be a need for improved devices and systems that usesurgical tapes, topical adhesives and their combinations such as thoseprovided by this invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a top view of a wound closure device comprising anon-symmetric, two-part release liner in accordance with an embodimentof the invention.

FIG. 2 depicts a wound-facing view of a wound closure device (prior toremoval of the release liners and prior to application to a wound)comprising a non-symmetric, two-part release liner in accordance with anembodiment of the invention.

FIGS. 3-6 depict edge views of a wound closure device comprising anon-symmetric, two-part release liner in accordance with an embodimentof the invention.

FIG. 7 depicts a first step for use of the device in accordance with theinvention.

FIG. 8 depicts a second step for use of the device in accordance withthe invention.

FIG. 9 depicts a third step for use of the device in accordance with theinvention.

FIG. 10 depicts a fourth step for use of the device in accordance withthe invention.

FIG. 11 depicts a fifth step for use of the device in accordance withthe invention.

FIG. 12 depicts an alternate embodiment of the device in accordance withthe invention which comprises several perforated segments of individualwound closure devices.

FIG. 13 depicts a bottom view of the wound closure device of FIG. 12(prior to removal of the release liners and prior to application to awound) comprising a non-symmetric, two-part release liner in accordancewith an embodiment of the invention.

FIG. 14 depicts a top view of the wound closure device of FIG. 12comprising a non-symmetric, two-part release liner in accordance with anembodiment of the invention

FIGS. 15, 16, 17 and 18 depict edge views of the wound closure device ofFIGS. 13 and 14 comprising a non-symmetric, two-part release liner inaccordance with an embodiment of the invention.

FIG. 19 depicts an alternate embodiment of the invention with the bottomview of a wound closure device (prior to removal of the release linersand prior to application to a wound) comprising a non-symmetric,two-part release liner in accordance with an embodiment of theinvention.

FIG. 20 depicts a top view of the wound closure device of FIG. 19comprising a non-symmetric, two-part release liner in accordance with anembodiment of the invention

FIGS. 21-24 depict edge views of the wound closure device depicted inFIGS. 19 and 20 comprising a non-symmetric, two-part release liner inaccordance with an embodiment of the invention.

FIG. 25 depicts a first step for use of the device in accordance withthe invention.

FIG. 26 depicts a second step for use of the device in accordance withthe invention.

FIG. 27 depicts a third step for use of the device in accordance withthe invention.

FIG. 28 depicts a fourth step for use of the device in accordance withthe invention.

FIG. 29 depicts a fifth step for use of the device in accordance withthe invention.

FIG. 30 depicts a sixth step for use of the device in accordance withthe invention.

SUMMARY OF THE INVENTION

One aspect of this invention is directed to a wound closure devicehaving a length A, a width B, an upper edge, a lower edge, a right-handedge, and a left-hand edge comprising:

a wound closure strip having a length A, a width F, a wound-facing side,a top side, an upper edge and a lower edge, the wound-facing sidecomprising an adhesive applied over at least a portion of the woundfacing side;

a release liner assembly detachably adhered to the wound closure stripby the adhesive, the release liner assembly consisting of a firstsection having a length A and a width E and a second section having alength A and a width D;

wherein the release liner assembly extends the full length A of thewound closure device and extends the full width B of the wound closuredevice, such that the release liner assembly forms a wound closurestrip-free tab, wherein the wound closure strip-free tab has a width ofG extending from the lower edge of the wound closure device to the loweredge of the wound closure strip;

wherein the width F of the wound closure strip is greater than the widthE of the first section by a width H, where H is equal to length D minuslength G; and

wherein the first section and the second section are separated from eachother by a liner cut.

In a preferred aspect of the invention,

the wound closure strip is porous;

the length A is from 2 to 20 cm and the width B from 1.7 to 12 cm;

the wound closure strip has a width F extending from the upper edge ofthe wound closure device and where F is from 1.5 to 8 cm;

the wound closure strip-free tab has a width G of 0.2 to 4.0 cm;

the first section of the release liner assembly has a width of Eextending from the upper edge of the wound closure device and is from1.5 to 8.0 cm and the second section of the release liner assembly has awidth D extending from the lower edge of the wound closure device isfrom 0.2 to 4 cm such that the width E of the first section is greaterthan the width D of the second section; and

the width B of the device is equal to the width E of the first sectionplus the width D of the second section.

A further aspect of this invention is directed toward a method ofclosing a wound having at least a first separated topical tissue surfaceand a second separated topical tissue surface comprising the steps of:

-   -   a) utilizing any one of the embodiments of the inventive wound        closure devices described herein and generally comprising a        wound closure strip, the wound closure strip comprising a wound        facing side and a top side, the wound facing side comprising an        adhesive applied over at least a portion of the wound facing        side and a non-symmetric, two-part release liner assembly        detachably adhered to the adhesive, the release liner assembly        comprising a first section and a second section with the second        section comprising a wound closure strip-free portion forming a        tab;    -   b) removing the first section of the release liner assembly to        expose a portion of the wound facing side of the wound closure        strip while grasping the tab of the second section of the        release liner assembly;    -   c) adhering a portion of the exposed wound facing side of the        wound closure strip to the at least first separated topical        tissue surface and pulling the tab of the second section of the        release liner toward the at least second separated topical        tissue surface to form two abutted topical tissue surfaces and        further adhering the exposed wound facing side of the wound        closure strip to the at least second topical tissue surface; and    -   d) removing the second section of the release liner assembly to        further expose a wound facing side of the wound closure strip        and adhering the further exposed wound closure strip the second        topical tissue surface.

The device used in the method of the invention may be any of the devicesdisclosed herein.

Desirably the method further comprises the step of applying a flowable,polymerizable adhesive over the adhered wound closure strip.

In alternate embodiments, the invention comprises a wound closure devicethat is multi-segmented and comprising several individual wound closuredevices.

Advantages of this invention include:

-   -   1) Minimization of adhesive transfer from the product to the        user's fingers/gloves, therefore maximizing grip to tissue.    -   2) Due to the presence of the second section of the release        liner, ease of repositioning the wound closure strip once        deployed on approximated wound edges.    -   3) Adhesive is present on only the side that is intended to be        in contact with tissue. So there is no accidental adherence of        objects to the wound closure strip side not in contact with        tissue.    -   4) Manipulation of the wound closure strip is stable during        tissue approximation as the second release paper section        provides sufficient rigidity.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

A key aspect for the improved ease of use of wound closure devices ofthis invention lies in the non-symmetric, two-part release linerassembly used in conjunction with a wound closure strip.

FIGS. 1 and 2 depict a top view and wound-facing view, respectively, ofone embodiment of the wound closure device 100 of the present inventionhaving upper edge 1, lower edge 2, right-hand edge 3 and left-hand edge4. Referring to FIGS. 1 and 2 , wound closure device 100 of length A andwidth B comprises wound closure strip 110 of length A, width F, andlower edge 6; and release liner assembly 140 having a cut 5 andconsisting of a first section 120 of length A and width E and secondsection 130 of length A and width D. It should be noted that dimension Crepresents the width past the midline of wound closure device 100 thatfirst section 120 extends; dimension H represents the overlap of woundclosure strip 110 with second section 130; and dimension G representsthe portion 7 of second section 130 that is free of wound closure strip110 and available for gripping device 100 without having to touch theadhesive containing wound contacting side of wound closure strip 110.

FIGS. 3, 4, 5 and 6 provide an upper edge view, a lower edge view, aleft-side edge view and a right-side edge view, respectively, of device100.

Typical and preferred dimensions for wound closure device 100 are:

Dimension Typical(cm) Most Preferred(cm) A 2.0-20.0 12.0 B 1.0-14   4.5C >0.0 1.0 D 0.5-4.0  1.5 E 0.6-10.0 3.0 F 1.0-8.0  3.5 G 0.2-4.0  1.0 H0.2-2    0.5

With respect to the various dimensions noted above, one skilled in theart would recognize that other dimensions for the wound closure deviceof this invention are possible depending on the specific dimensions oneskilled in the art may select and adapt to treat wounds or incisions ofvarious sizes and shapes. Additionally, for example, referring to FIG. 1, it is envisioned that wound closure strip 110 perimeter p need not becoextensive with portions of device 100 perimeter p′, and can bepartially coextensive or not be coextensive at all depending if a marginbetween wound closure strip 110 and release liner assembly 140 isdesired.

In general, device 100 may be of any length A and width B that permitsthe user to effectively apply to close a wound or incision. For manyapplications, length A will typically range from about 2 cm to about 20cm, preferably from about 10 cm to about 15 cm, and most preferablyabout 12 cm. Width B will typically range from about 1.0 cm to about 14cm, preferably from about 2 to about 10 cm, and most preferably about4.5 cm.

Additionally, wound closure strip 110 may be of any length A and width Fthat permits the user to effectively apply to close a wound or incision.For many applications, length A will typically range from about 2 cm toabout 20 cm, preferably from about 10 cm to about 15 cm, and mostpreferably about 12 cm. Width F will typically range from about 1.0 cmto about 8 cm, preferably from about 2 cm to about 6 cm, and mostpreferably about 3.5 cm.

Dimension C, the distance between the Midline of wound closure device100 and release liner cut 5 between first section 120 and second section130. It is dimension C that makes the release assembly a non-symmetric,two-part assembly. If dimension C was equal to 0 cm, then the releaseassembly would no longer be non-symmetric as then the release assemblycut 5 would be at the Midline and hence the first release section 120and the second release section 130 would be of equal width. So dimensionC should be greater than 0 and ranges from 0.1 cm to about 2 cm,preferably from about 0.5 cm to about 1.5 cm, and most preferably about1.0 cm.

Dimension D ranges from 0.5 cm to about 4 cm, preferably from about 0.7cm to about 3 cm, and most preferably about 1.5 cm. It is within theforegoing ranges that device 100 is conveniently handled with sufficientoverlap of wound closure strip 110 and second section 130 to adequatelyaccomplish approximation of the separated topical tissue surface of awound.

Dimension E is the width of the first section 120 and relates to thewidth of wound closure strip 110 that is suitable for the user toposition and/or reposition wound closure strip 110 for the initialapproximation of the separated topical tissue surfaces of a wound.Dimension E ranges from 0.6 cm to about 10 cm, preferably from about 2.0cm to about 5 cm, and most preferably about 3.0 cm. It is within theforegoing ranges that wound close strip 110 adequately approximates andcover wounds ranging in sizes from 1 cm to about 20 cm.

Dimension G ranges from 0.2 cm to about 4 cm, preferably from about 0.5cm to about 3 cm, and most preferably about 1.0 cm. It is within theforegoing ranges that device 100 is conveniently handled withoutdenigrating the pressure sensitive adhesive of the wound-face side ofwound closure strip 110.

Dimension H ranges from 0.2 cm to about 2.0 cm, preferably from about0.3 cm to about 1.0 cm, and most preferably about 0.5 cm. It is withinthe foregoing ranges that device 100 is conveniently handled withsufficient adherence of second section 130 to wound closure strip 110 toaccomplish approximation of the wound.

For treatment of surgical wound incisions of about 1.0 cm to about 12cm, a preferred embodiment of device 100 is for an overall length A ofabout 12 cm and overall width B of about 4.5 cm, wound closure strip 110of overall length A of about 12 cm and overall width F of about 3.5 cm,Dimension C of about 1.0 cm, Dimension D of about 1.5 cm, Dimension E ofabout 3.0 cm, Dimension G of about 1.0 cm and Dimension H of about 0.5cm.

It would be appreciated by one of skill in the art that device 100 maybe cut or trimmed to size for wounds within the above identified range.In practice, it is desirable to have wound closure strip 110 extendapproximately at least 0.3 cm, preferably 1 cm from the longitudinalends of the wound or incision site.

Alternate embodiments of this invention are contemplated wherein thedevice comprises a wound closure device that is multi-segmented andcomprises several individual wound closure devices as shown in FIGS.12-24 . A method of using such devices is shown in FIGS. 25-30 .

Referring to FIG. 12 , device 100 comprises wound closure strip 110 andrelease liner assembly 140 having a first section 120 and a secondsection 130 separated by cut 5. Device 100 further comprises severalperforated segments of individual wound closure devices 100 a, 100 b,100 c, 100 d, and 100 e. This embodiment demonstrates the versatility ofthe invention in being able to provide an array of devices that may bemore suitable for the closure of smaller incisions, such as those madein laparoscopic procedures having incisions in the range of 0.5-1.5 cm.Also in this embodiment, wound closure strip 110 is coextensive withrelease liner assembly 140. An alternative embodiment where woundclosure strip 110 is not coextensive with release liner assembly 140 isdescribed below.

FIG. 13 depicts the bottom view of the wound closure device 100 of FIG.12 (prior to separation from the multi-segmented array, removal of therelease liners and application to a wound) of overall segmented lengthA′ and width B comprising a non-symmetric, two-part release liner. Morespecifically, segmented devices 110 a, 100 b, 100 c, 100 d and 100 e areseparated by perforations pa, pb, pc, and pd, respectively. Furtherreferring to segmented device 100 a, this device of length A and width Bcomprises top side edge 1, bottom side edge 2, left edge 3 and rightedge 4.

FIG. 14 depicts a top view of the wound closure device 100 of FIG. 12comprising a non-symmetric, two-part release liner assembly 140comprising first section 120 of width E and second section 130 of widthD separated by cut 5.

FIGS. 15, 16, 17 and 18 depict an upper edge view, a lower edge view, aleft-side edge view and a right-side edge view, respectively, of device100.

Typical and preferred dimensions for wound closure device 100 a of FIGS.13 and 14 are:

Dimension Typical (cm) Preferred range (cm) Most Preferred (cm) A′ 5.0-40.0 6.5-25 15 A 1.0-8.0 1.5-5  3 B 1.0-10  1.5-5  3 C >0.0 0.1-2 1.0 D 0.5-4.0 0.5-3  1.5 E 0.5-6    1-5 1.5

In general, and particularly referring to device 100 a of FIG. 13 ,device 100 a may be of any length A and width B that permits the user toeffectively apply to close a wound or incision. Dimension A′, theoverall length of the multi-segmented device 100, shall vary as afunction of the length A varies. For example, for device 100 comprising5 individual wound closure device segments (i.e., 100 a, 100 b, 100 c,100 d, and 100 e), length A′ would be five times the length A. For manyapplications, length A will typically range from about 1 cm to about 8cm, preferably from about 1.5 cm to about 5 cm, and most preferablyabout 3 cm. Width B will typically range from about 1.0 cm to about 12cm, preferably from about 1.5 to about 7 cm, and most preferably about3.0 cm.

Additionally, wound closure strip 110 a may be of any length A thatpermits the user to effectively apply to close a wound or incision. Formany applications, length A will typically range from about 1 cm toabout 8 cm, preferably from about 1.5 cm to about 5 cm, and mostpreferably about 3 cm.

Dimension C, is the distance between the Midline of wound closure device100 a and release liner cut 5 between first section 120 and secondsection 130. It is dimension C that makes the release assembly anon-symmetric, two-part assembly. If dimension C was equal to 0 cm, thenthe release assembly would no longer be non-symmetric as then therelease assembly cut 5 would be at the Midline and hence the firstrelease section 120 and the second release section 130 would be of equalwidth. So dimension C should be greater than 0 and preferably rangesfrom 0.1 cm to about 2 cm and most preferably about 1.0 cm.

Dimension D ranges from 0.5 cm to about 4 cm, preferably from about 0.5cm to about 3 cm, and most preferably about 1.5 cm. It is within theforegoing ranges that device 100 a is conveniently handled withsufficient overlap of wound closure strip 110 and second section 130 toadequately accomplish approximation of the separated topical tissuesurface of a wound.

Dimension E is the width of the first section 120 and relates to thewidth of wound closure strip 110 a that is suitable for the user toposition and/or reposition wound closure strip 110 a for the initialapproximation of the separated topical tissue surfaces of a wound.Dimension E ranges from 0.5 cm to about 6 cm, preferably from about 1.0cm to about 5 cm, and most preferably about 1.5 cm. It is within theforegoing ranges that wound close strip 110 a adequately approximatesand cover wounds ranging in sizes from 0.25 cm to about 7 cm.

With respect to the various dimensions noted above, one skilled in theart would recognize that other dimensions for the wound closure deviceof this invention are possible depending on the specific dimensions oneskilled in the art may select and adapt to treat wounds or incisions ofvarious sizes and shapes. Additionally, for example, referring to FIG.13 , it is envisioned that wound closure strip 110 (100 a) perimeterneed not be coextensive with portions of device 100 (100 a) perimeter,and can be partially coextensive or not be coextensive at all dependingif a margin between wound closure strip 110 and release liner assembly140 is desired.

For treatment of surgical wound incisions of about 2 cm, a preferredembodiment of device 100 a is for an overall length A of about 4 cm andoverall width B of about 4.5 cm, wound closure strip 110 a of overalllength A of about 4 cm and overall width F of about 3.5 cm, Dimension Cof about 1.0 cm, Dimension D of about 1.5 cm, Dimension E of about 3.0cm, Dimension G of about 1.0 cm and Dimension H of about 0.5 cm.

It would be appreciated by one of skill in the art that device 100 a maybe cut or trimmed to size, or even over layed for wounds within theabove identified ranges. In practice, it is desirable to have woundclosure strip 110 a extend approximately at least 0.3 cm, preferably 1cm from the longitudinal ends of the wound or incision site. Also as anexample of an over lay, it is envisioned that a wound of 7 cm in lengthmay be closed using 3 wound closure strips 100 a of 3 cm in length. Overlaying multiple wound closure strips 110 a provide an advantage ofclosing wound that may have curvilinear shapes.

FIG. 19 depicts an alternate embodiment of the invention with the bottomview of a wound closure device 100 (prior to separation from themulti-segmented array, removal of the release liners and application toa wound) comprising a non-symmetric, two-part release liner of overalllength A′ and width. More specifically, segmented devices 110 a, 100 b,100 c, 100 d and 100 e are separated by perforations pa, pb, pc, and pd,respectively. Further referring to segmented device 100 a, this deviceof length A and width B comprises top side edge 1, bottom side edge 2,left edge 3 and right edge 4. This embodiment is an example of aninstance that wound closure strip 110 perimeter is not coextensive withthe perimeter of device 100.

FIG. 20 depicts a top view of the wound closure device 100 of FIG. 19comprising a non-symmetric, two-part release liner.

FIGS. 21, 22, 23 and 24 depict an upper edge view, a lower edge view, aleft-side edge view and a right-side edge view, respectively, of device100 as depicted in FIGS. 19 and 20 .

Typical and preferred dimensions for wound closure device 100 a of FIGS.19 and 20 are:

Dimension Typical (cm) Preferred range Most Preferred (cm) A′  5.0-40.06.5-25 15 A 1.0-8.0 1.5-5  3 B 1.0-12  1.5-7  5 C >0.0 0.1-2  1.0 D0.5-5   0.5-4  2 E 0.5-7    1-5 3 F 1.0-8.0 1.5-5  3 G 0.25-4.0  0.5-2 1.0 H 0.25-4   0.5-2  1

With respect to the various dimensions noted above, one skilled in theart would recognize that other dimensions for the wound closure deviceof this invention are possible depending on the specific dimensions oneskilled in the art may select and adapt to treat wounds or incisions ofvarious sizes and shapes.

In general, device 100 a may be of any length A and width B that permitsthe user to effectively apply to close a wound or incision. DimensionA′, the overall length of the multi-segmented device 100, shall vary asa function of the length A varies. For example, for device 100comprising 5 individual wound closure device segments (i.e., 100 a, 100b, 100 c, 100 d, and 100 e), length A′ would be five times the length A.For many applications, length A will typically range from about 1 cm toabout 8 cm, preferably from about 1.5 cm to about 5 cm, and mostpreferably about 3 cm. Width B will typically range from about 1.0 cm toabout 12 cm, preferably from about 1.5 to about 7 cm, and mostpreferably about 5 cm.

Additionally, wound closure strip 110 a may be of any length A and widthF that permits the user to effectively apply to close a wound orincision. For many applications, length A will typically range fromabout 1 cm to about 8 cm, preferably from about 1.5 cm to about 5 cm,and most preferably about 3 cm. Width F will typically range from about1.0 cm to about 8 cm, preferably from about 2 cm to about 6 cm, and mostpreferably about 3.5 cm.

Dimension C, the distance between the Midline of wound closure device100 and release liner cut 5 between first section 120 and second section130. It is dimension C that makes the release assembly a non-symmetric,two-part assembly. If dimension C was equal to 0 cm, then the releaseassembly would no longer be non-symmetric as then the release assemblycut 5 would be at the Midline and hence the first release section 120and the second release section 130 would be of equal width. So dimensionC should be greater than 0 and ranges from 0.1 cm to about 2 cm,preferably from about 0.5 cm to about 1.5 cm, and most preferably about1.0 cm.

Dimension D ranges from 0.5 cm to about 5 cm, preferably from about 0.5cm to about 4 cm, and most preferably about 2 cm. It is within theforegoing ranges that device 100 is conveniently handled with sufficientoverlap of wound closure strip 110 a and second section 130 toadequately accomplish approximation of the separated topical tissuesurface of a wound.

Dimension E is the width of the first section 120 and relates to thewidth of wound closure strip 110 a that is suitable for the user toposition and/or reposition wound closure strip 110 a for the initialapproximation of the separated topical tissue surfaces of a wound.Dimension E ranges from 0.5 cm to about 7 cm, preferably from about 1.0cm to about 5 cm, and most preferably about 3.0 cm. It is within theforegoing ranges that wound close strip 110 a adequately approximatesand covers wounds ranging in sizes from 0.25 cm to about 7 cm.

Dimension G ranges from 0.25 cm to about 4 cm, preferably from about 0.5cm to about 2 cm, and most preferably about 1.0 cm. It is within theforegoing ranges that device 100 a is conveniently handled withoutdenigrating the pressure sensitive adhesive of the wound-face side ofwound closure strip 110 a.

Dimension H ranges from 0.25 cm to about 4.0 cm, preferably from about0.5 cm to about 2.0 cm, and most preferably about 1 cm. It is within theforegoing ranges that device 100 a is conveniently handled withsufficient adherence of second section 130 to wound closure strip 110 ato accomplish approximation of the wound.

For treatment of surgical wound incisions of about 2 cm, a preferredembodiment of device 100 a is for an overall length A of about 4 cm andoverall width B of about 4.5 cm, wound closure strip 110 a of overalllength A of about 4 cm and overall width F of about 3.5 cm, Dimension Cof about 1.0 cm, Dimension D of about 1.5 cm, Dimension E of about 3.0cm, Dimension G of about 1.0 cm and Dimension H of about 0.5 cm.

It would be appreciated by one of skill in the art that device 100 a maybe cut or trimmed to size, or even over layed for wounds within theabove identified ranges. In practice, it is desirable to have woundclosure strip 110 a extend approximately at least 0.3 cm, preferably 1cm from the longitudinal ends of the wound or incision site. Also as anexample of an over lay, it is envisioned that a wound of 7 cm in lengthmay be closed using 3 wound closure strips 100 a of 3 cm in length. Overlaying multiple wound closure strips 110 a provide an advantage ofclosing wound that may have curvilinear shapes.

Wound closure strips suitable for use in this invention comprise anysuitable strip that is adaptable to close a wound. Preferably, the woundclosure strip is porous and will allow a flowable, polymerizableadhesive to permeate the strip and to allow adequate bonding of thestrip to a tissue surface being bonded.

The wound closure strip comprises a wound facing side and a top side.The wound facing side further comprises an adhesive such as a pressuresensitive adhesive (PSA) applied over at least a portion of the woundfacing side. The adhesive may be provided over the entire wound facingside of the wound closure strip. The PSA is useful for initiallyapproximating the wound. The wound closure strip is preferably porous.By “porous” is meant herein either that the bulk of the wound closurestrip has pores, such that subsequently applied polymerizable adhesivecomposition is soaked up or absorbed by the bulk material, or that thebulk of the wound closure strip has voids (like a net or screen), suchthat the subsequently applied polymerizable adhesive composition passesdirectly through the bulk material, with or without being soaked up orabsorbed by the bulk material. For example, in the case of textilematerials, “porous” is generally used to mean that the applied adhesivecomposition permeates and passes through interstices between the fibers,but does not necessarily pass into and through the fibers themselves.Preferably the wound closure strip is a mesh.

Such porosity (or other properties such as hydrophobicity orhydrophilicity) will also allow a polymerization initiator or ratemodifier to be loaded in or on the wound closure strip prior to use, toinitiate the subsequently applied polymerizable adhesive composition.Such porosity will also preferably allow air and fluid to pass throughthe wound closure strip, either through pores per se, or through voidsin the bulk material. Depending upon the degree of porosity and/or thesize of the openings, such porosity of the mesh or ability of air andfluid to permeate through the mesh may be tailored either to remainafter a final composite material is formed, or to be absent therefrom.The wound closure strip is also preferably non-toxic, as it is intendedto be used cover a wound, such as on biological tissues. As such, thewound closure strip should be biologically compatible with the desiredsubstrate (such as tissue, skin, organ, or the like), and is preferablya material that is governmentally approved or generally regarded as safefor the desired purpose. By way of example, suitable wound closurestrips are mesh materials and are disclosed in United States PatentApplications 2006/0009099 and 2005/0182443, incorporated herein byreference in their entirety.

Suitable wound closure strip materials may be formed of either syntheticor natural materials. Such material may be formed of either woven ornon-woven fabrics or materials. The wound closure strip may be, forexample, any suitable polymeric film, plastic foam (including opencelled foam), a woven fabric, knitted fabric, a non-woven fabric,mixture thereof, or the like.

In particular, suitable wound closure strips may thus be prepared, forexample, from nylon, a polyolefin film, such as polyethylene,polypropylene, ethylene propylene copolymers, and ethylene butylenecopolymers, polyurethanes, polyurethane foams, polystyrenes, plasticizedpolyvinylchlorides, polyesters, polyamides, polylactic acid,polyglycolic acid, polycaprolactone, copolymer mixtures of the above,and cotton. Suitable specific examples include, for example, nylon,polyethylene, polypropylene, ethylene propylene copolymers, ethylenebutylene copolymers, polyurethane, polystyrene, plasticizedpolyvinylchloride, polyester, polyamide, cotton, polytetrafluoroethylene(PTFE), biovascular material, collagen, Gore-Tex®, DACRON®, etc.

The wound closure strip may be formed of a synthetic, semi-synthetic, ornatural organic material. Thus, for example, the wound closure strip maybe formed of a synthetic or natural polymer material, but not from amaterial such as metal (such as silver, steel or the like) or glass orceramic. The wound closure strip may be either biodegradable, or notbiodegradable. The wound closure strip is preferably resistant totearing.

The thickness of the wound closure strip may be from about 0.05 mm toabout 10 mm. In another embodiment, the thickness of the wound closurestrip is from about 0.1 mm to about 7 mm, preferably from about 0.3 mmto about 5 mm, most preferably from about 0.3 mm to about 3 mm.

The wound closure strip may be selected to be elastic or have somememory effect. In such embodiments, the elastic properties of the meshmay desirably provide a degree of pressure or stress at the applicationsite, for example, to maintain wound edge approximation. Likewise, inembodiments where such additional degree of pressure or stress at theapplication site is not desired, the mesh may be selected to have lessor no elasticity.

The wound closure strip may be either biodegradable, or notbiodegradable. By “biodegradable” is meant that the mesh biodegradesover time in vivo, such that it does not require physical removal of themesh after a set period of time. Thus, for example, a biodegradable meshis one that, in the in vivo environment, will biodegrade over a periodof from about one week to about five years. A non biodegradable materialis one that does not biodegrade in an in vivo environment within aboutfive years. Such a non biodegradable material thus would requirephysical removal of the wound closure strip at a desired time, ratherthan slowly deteriorating over time or may slough off naturally from thetissue.

The wound closure strip preferably includes one or more chemicalmaterials located in or on it. For example, one or more chemicalsubstances may be dispersed in or on the wound closure strip, such asbeing chemically bound, physically bound, absorbed, or adsorbed to it.Thus, for example, the wound closure strip preferably includes at leasta polymerization initiator or rate modifier, and may optionally includeone or more bioactive materials. As desired, the one or more chemicalsubstances may be either immobilized in or on the wound closure strip,for example, so that it has a desired effect but is not detached fromthe wound closure strip during use.

For example, a polymerization initiator or rate modifier may be loadedin or on the wound closure strip so that the initiator or rate modifierprovides the desired initiation or rate modification effect to asubsequently applied polymerizable adhesive composition. Thepolymerization initiator or rate modifier may be immobilized in or onthe wound closure strip, so that the initiator or rate modifier does notbecome detached from the wound closure strip and its residues aredispersed in the resultant polymeric material. Alternatively, forexample, the polymerization initiator or rate modifier may be initiallyattached to the wound closure strip, but only in such a manner that itbecomes mobilized or solubilized by a subsequently applied polymerizableadhesive composition and dispersed in the resultant polymeric material.

If desired, a combination of chemical substances may also be provided inor on the wound closure strip, to provide multiple effects. For example,as described above, a first chemical species (such as a polymerizationinitiator or rate modifier) may be immobilized in or on the woundclosure strip, while a second, different chemical species (such as abioactive material) may be detachably attached to the wound closurestrip. Other combinations of chemical species and resultant effects arealso envisioned.

The chemical substance may be applied in a uniform manner to the woundclosure strip, such that there is a substantially uniform concentrationof the chemical substance across the wound closure strip. Alternatively,the chemical substance may be applied such that a concentration gradientexists across or through the wound closure strip. For example, a greateror smaller concentration of the chemical substance could exist at thecenter or edges of the wound closure strip, or a greater or smallerconcentration of the chemical substance could be applied on one side ofthe wound closure strip as compared to an opposite side. Further, thechemical substance may be applied in a uniform manner to the woundclosure strip, or it may be applied in a non-uniform random or patternedmanner (such as lines, dots, concentric circles, or the like). Thechemical substances may also be on, beneath, or in the adhesive layerapplied to the wound closure strip.

When present in or on the wound closure strip, the chemical substances(i.e., polymerization initiator, rate modifier, and/or bioactivematerials, or other additives), may be incorporated in or on the woundclosure strip in any suitable manner. For example, the chemicalsubstance may be wound closure strip added to the wound closure strip bycontacting the wound closure strip with a solution, mixture, or the likeincluding the chemical substances. The chemical substance may be addedto the wound closure strip, for example, by dipping, spraying, rollcoating, gravure coating, brushing, vapor deposition, or the like.Alternatively, the chemical substance may be incorporated into or ontothe wound closure strip during manufacture of the wound closure strip,such as during molding, knitting/weaving, scouring, tenting, plaiting orother processing or the like of the wound closure strip.

Other chemical substances that may be present in or on the wound closurestrip include, but are not limited to, any suitable and preferablycompatible additive that enhances performance of the compositestructure. Such additional chemical substances may be bioactive ornon-bioactive. Suitable other chemical substances thus include, but arenot limited to, colorants (such as inks, dyes and pigments), scents,protective coatings that do not chemically detach, temperature sensitiveagents, drugs, wound-healing agents, anti-microbial agents and the like.

The polymerization initiator or rate modifier loaded in or on the woundclosure strip may provide a number of advantages for example, thetailoring of the setting or polymerization time of the appliedpolymerizable adhesive composition. For example, the type and/orconcentration of initiator that is applied to the wound closure stripmay be selected so as to provide faster or slower polymerization time.The concentration of polymerization initiator or rate modifier may beincreased to provide a faster polymerization time, or may be decreasedto provide a slower polymerization time.

Because the polymerization initiator or rate modifier is loaded directlyin or on the wound closure strip, it is not necessary to mix thepolymerizable adhesive composition with a polymerization initiator orrate modifier prior to application. This may allow a longer workingtime, where the polymerizable monomer composition may be more preciselyand carefully applied over a longer period of time.

Such suitable initiators are known in the art and are described, forexample, in U.S. Pat. Nos. 5,928,611 and 6,620,846, both incorporatedherein by reference in their entireties, and U.S. Patent Application No.2002/0037310, also incorporated herein by reference in its entirety.Quaternary ammonium chloride and bromide salts useful as polymerizationinitiators are particularly suitable. By way of example, quaternaryammonium salts such as domiphen bromide, butyrylcholine chloride,benzalkonium bromide, acetyl choline chloride, among others, may beused.

Benzalkonium or benzyltrialkyl ammonium halides such as benzyltrialkylammonium chloride may be used. When used, the benzalkonium halide may bebenzalkonium halide in its unpurified state, which comprises a mixtureof varying chain-length compounds, or it can be any suitable purifiedcompound including those having a chain length of from about 12 to about18 carbon atoms, including but not limited to C12, C13, C14, C15, C16,C17, and C18 compounds. By way of example, the initiator may be aquaternary ammonium chloride salt such as benzyltrialkyl ammoniumchloride (B TAC).

Other initiators or accelerators may also be selected by one of ordinaryskill in the art without undue experimentation. Such suitable initiatorsor accelerators may include, but are not limited to, detergentcompositions; surfactants: e.g., nonionic surfactants such aspolysorbate 20 (e.g., Tween 20™ from ICI Americas), polysorbate 80(e.g., Tween 80™ from ICI Americas) and poloxamers, cationic surfactantssuch as tetrabutylammonium bromide, anionic surfactants such as sodiumtetradecyl sulfate, and amphoteric or zwitterionic surfactants such asdodecyldimethyl(3-sulfopropyl)ammonium hydroxide, inner salt; amines,imines and amides, such as imidazole, arginine and povidine; phosphines,phosphites and phosphonium salts, such as triphenylphosphine andtriethyl phosphite; alcohols such as ethylene glycol, methyl gallate;tannins; inorganic bases and salts, such as sodium bisulfite, calciumsulfate and sodium silicate; sulfur compounds such as thiourea andpolysulfides; polymeric cyclic ethers such as monensin, nonactin, crownethers, calixarenes and polymeric-epoxides; cyclic and acycliccarbonates, such as diethyl carbonate; phase transfer catalysts such asAliquat 336; organometallics such as cobalt naphthenate and manganeseacetylacetonate; and radical initiators or accelerators and radicals,such as di-t-butyl peroxide and azobisisobutyronitrile.

Mixtures of two or more, such as three, four, or more, initiators oraccelerators may be used. A combination of multiple initiators oraccelerators may be beneficial, for example, to tailor the initiator ofthe polymerizable monomer species. For example, where a blend ofmonomers is used, a blend of initiators may provide superior results toa single initiator. For example, the blend of initiators can provide oneinitiator that preferentially initiates one monomer, and a secondinitiator that preferentially initiates the other monomer, or canprovide initiation rates to help ensure that both monomer species areinitiated at equivalent, or desired non-equivalent, rates. In thismanner, a blend of initiators can help minimize the amount of initiatornecessary. Furthermore, a blend of initiators may enhance thepolymerization reaction kinetics. The polymerization initiator,accelerator, rate-modifier, and/or cross-linking agent may beincorporated into the mesh using impregnation methods known in the art.

The two-part release liner assembly is a backing film comprisingindividually peelable sections. The first section 120 is coextensivewith at least a portion of wound closure strip 110 and is of largerwidth compared to the second section 130. Second section 130 comprisesat least a portion that is not coextensive with the wound closure strip110. This non-coextensive portion of section 130 permits manipulationand placement of wound closure strip 110 without disturbing ordenigrating the pressure sensitive adhesive contained on thewound-facing side of wound closure strip 110. In some instances, it iscontemplated that second section 130 may be wider than first section 120to aid in manipulation and gripping of the wound closure device as theseparated topical tissue surfaces are being approximated.

The material for the invention's release liner assembly may be anysuitable backing or release material used to cover the adhesivesubstances applied to the wound facing side of the wound closure strip.Such backing materials are well known in the art for covering adhesivesand can include, for example, paper, plastic, or the like. By way ofexample, the release liner assembly may be a silicone treated material.Preferably, the release liner assembly is of a material that prevents oreliminates the wound closure strip from sticking to itself.

The method of wound closure or tissue bonding herein disclosed includesa polymerizable adhesive composition applied over the wound closurestrip after the wound closure strip is applied to a tissue or woundsite. The polymerizable adhesive composition may comprise apolymerizable monomeric adhesive. In embodiments, the polymerizableadhesive composition comprises a polymerizable 1,1-disubstitutedethylene monomer formulation. In embodiments, the polymerizable adhesivecomposition comprises a cyanoacrylate formulation. In embodiments,synthetic polymerizable adhesive materials such as polyurethane,polyethylene glycol, acrylates, glutaraldehyde and biologically basedadhesives may be used.

Suitable α-cyanoacrylate monomers which may be used, alone or incombination, include alkyl α-cyanoacrylates such as 2-octylcyanoacrylate; dodecyl cyanoacrylate; 2-ethylhexyl cyanoacrylate; butylcyanoacrylate such as n-butyl cyanoacrylate; ethyl cyanoacrylate; methylcyanoacrylate or other α-cyanoacrylate monomers such as methoxyethylcyanoacrylate; 2-ethoxyethyl cyanoacrylate; 3-methoxybutylcyanoacrylate; 2-butoxyethyl cyanoacrylate; 2-isopropoxyethylcyanoacrylate; and 1-methoxy-2-propyl cyanoacrylate. In embodiments, themonomers are ethyl, n-butyl, or 2-octyl α-cyanoacrylate. Othercyanoacrylate monomers which may be used include alkyl estercyanoacrylates, such as those prepared by the Knoevenagel reaction of analkyl cyanoacetate, or an alkyl ester cyanoacetate, withparaformaldehyde, subsequent thermal cracking of the resultant oligomerand distillation.

The wound closure device herein disclosed may be provided in a kitcomprising additional components. The kit may comprise at least onewound closure strip as herein described, and one or more containers ofpolymerizable adhesive composition. The different components or groupsof components may be sterilized in separate containers before packagingthe components or groups of components within a kit, and thereaftersterilizing the kit as disclosed in co-assigned U.S. Pre-grant PatentPublication No. 2004/0120849, incorporated herein by reference in itsentirety.

The adhesive substance used on the wound closure strip may, for example,be any suitable adhesive substance. Preferably, the adhesive substanceis a medical grade adhesive, such as acrylic based pressure sensitiveadhesives (PSAs), rubber based pressure sensitive adhesives, siliconepressure sensitive adhesives, mixtures thereof, or the like. It ispreferred that the adhesive substance be different from thepolymerizable adhesive composition. Thus, for example, it is preferredthat while the polymerizable adhesive composition can be, for example, apolymerizable monomeric adhesive composition, the adhesive substance isa material that is not a polymerizable adhesive composition, such as apressure sensitive adhesive.

Suitable rubber based PSAs include, but are not limited to, those taughtin U.S. Pat. No. 5,705,551 and in U.S. Pat. No. 4,080,348, thedisclosures of which are hereby incorporated by reference. Examples ofpolymeric rubber bases include one or more of styrene-isoprene-styrenepolymers, styrene-olefin-styrene polymers includingstyrene-ethylene/propylene-styrene polymers, polyisobutylene,styrene-butadiene-styrene polymers, polyisoprene, polybutadiene, naturalrubber, silicone rubber, acrylonitrile rubber, nitrile rubber,polyurethane rubber, polyisobutylene rubber, butyl rubber, halobutylrubber including bromobutyl rubber, butadiene-acrylonitrile rubber,polychloroprene, and styrene-butadiene rubber.

A particularly useful rubber based adhesive is that which has athermoplastic elastomeric component and a resin component. Thethermoplastic elastomeric component contains about 55-85 parts of asimple A-B block copolymer wherein the A-blocks are derived from styrenehomologs and the B-blocks are derived from isoprene, and about 15-45parts of a linear or radical A-B-A block copolymer wherein the A-blocksare derived from styrene or styrene homologs and the B-blocks arederived from conjugated dienes or lower alkenes, the A-blocks in the A-Bblock copolymer constituting about 10-18 percent by weight of the A-Bcopolymer and the total A-B and A-B-A copolymers containing about 20percent or less styrene. The resin component consists of essentially oftackifier resins for the elastomeric component. In general, anycompatible conventional tackifier resin or mixture of such resins may beused. These include hydrocarbon resins, rosin and rosin derivatives,polyterpenes and other tackifiers. The adhesive substance may containabout 20-300 parts of the resin component per one hundred parts byweight of the thermoplastic elastomeric component. One such rubber basedadhesive substance is commercially available from Ato Findley under thetrade name HM3210.

Useful acrylic based PSAs include, but are not limited to, those taughtin U.S. Pat. Nos. 5,947,917 and 5,164,444 (acrylic emulsion), U.S. Pat.No. 5,623,011 (tackified acrylic emulsion). It can also be radiationcurable mixture of monomers with initiators and other ingredients suchas those taught in U.S. Pat. No. 5,232,958 (UV cured acrylic) and U.S.Pat. No. 5,232,958 (EB cured). The disclosures of these patents arehereby incorporated by reference.

It is contemplated that any acrylic based polymer capable of forming anadhesive layer with sufficient tack to adhere to the wound closurestrip, the backing film or to a substrate, and with acceptable adhesionto skin, may be used. In certain embodiments, the acrylic polymers forthe pressure-sensitive adhesive layers include those formed frompolymerization of at least one alkyl acrylate monomer or methacrylate,an unsaturated carboxylic acid and optionally a vinyl lactam. Examplesof suitable alkyl acrylate or methacrylate esters include, but are notlimited to, butyl acrylate, ethyl acrylate, 2-ethylhexyl acrylate,isooctyl acrylate, isononyl acrylate, isodecyl acrylate, methylacrylate, methylbutyl acrylate, 4-methyl-2-pentyl acrylate, sec-butylacrylate, ethyl methacrylate, isodecyl methacrylate, methylmethacrylate, and the like, and mixtures thereof. Examples of suitableethylenically unsaturated carboxylic acids include, but are not limitedto, acrylic acid, methacrylic acid, fumaric acid, itaconic acid, and thelike, and mixtures thereof. A preferred ethylenically unsaturatedcarboxylic acid monomer is acrylic acid. Examples of suitable vinyllactams include, but are not limited to, N-vinyl caprolactam,1-vinyl-2-piperidone, 1-vinyl-5-methyl-2-pyrrolidone-, vinylpyrrolidone, and the like, and mixtures thereof.

Useful silicone pressure sensitive adhesives include those commerciallyavailable from Dow Corning Corp., Medical Products and those availablefrom General Electric. Examples of silicone adhesives available from DowCorning include those sold under the trademarks BIO-PSA X7-3027, BIO-PSAX7-4919, BIO-PSA X7-2685, BIO-PSA X7-3122 and BIO-PSA X7-4502.Additional examples of silicone pressure sensitive adhesives aredescribed in U.S. Pat. Nos. 4,591,622, 4,584,355, 4,585,836 and4,655,767, the entire disclosures of which are incorporated herein byreference.

The adhesive substance may also include one or more tackifiers,plasticizers, antioxidants, cutting agents such as waxes, andsurfactants. Other optional materials that may be added to the adhesivesubstance layer in minor amounts (typically less than about 25% byweight of the elastomeric phase) include pH controllers, medicaments,bactericides, growth factors, wound healing components such as collagen,antioxidants, deodorants, perfumes, antimicrobials and fungicides.

FIGS. 7 to 11 depict steps for the use of the device of this invention.

In particular and referring to FIG. 7 , once a suitable wound W has beenidentified for closure of tissue T by joining topical tissue surface TS₁with topical tissue surface TS₂, first section 120 of wound closuredevice 100 is removed by grasping and pulling section 120 (for example,with left hand, LH) while holding second section 130 (for example withright hand RH) to separate first section 120 from wound closure strip110. Next, FIG. 8 illustrates the device being positioned axially alonga side of wound W of tissue T and contacting a first separated topicaltissue surface TS₁. FIG. 9 depicts tissue surface TS₁ on one side ofwound W being pulled to approximate a second separated topical tissuesurface TS₂ of wound W to the first separated topical tissue surface TS₁of wound W by pulling second section 130. FIG. 10 shows second section130 being removed from wound closure strip 110 and wound closure strip110 being more firmly secured to topical tissue surface TS₂ by the user.Once wound closure strip 110 is firmly contacting tissue T and hasapproximated TS₁ to TS₂ of wound W, FIG. 11 illustrates application of asuitable flowable, polymerizable adhesive being applied from applicator800 which permeates wound closure strip 110 to form film 810.

FIGS. 25-30 depict typical steps used in a method of applying a segmentof the multi-segmented device embodiment to wound W of tissue T byjoining topical tissue surface TS₁ with topical tissue surface TS₂.Referring to these figures, the user accomplishes the method for theclosing of a wound comprising the steps of:

-   -   a) grasping multi-segmented device 100; (FIG. 25 )    -   b) separating segment 100 a from device 100; (FIG. 26 )    -   c) removing first section 120 of release liner 140 from device        100 a to expose wound closure strip 110 a coated with a pressure        sensitive adhesive; (FIG. 27 )    -   d) positioning wound closure strip 110 axially along a side of        wound W of tissue T and contacting a first separated topical        tissue surface TS₁ and pulling wound closure strip 110 across        wound W to approximate and join topical tissue surface TS₁ with        topical tissue surface TS₂, (FIG. 28 )    -   e) removing second section 130 of release liner 140; (FIG. 29 )        and    -   f) optionally applying a polymerizable liquid adhesive from        applicator 800 to form film 810 over wound closure strip 110.        (FIG. 30 )

Advantages of the methods, devices and systems of this inventioninclude: clear visualization for placement of wound closure strip 110 toapproximate wound W by abutting the separate topical tissue surfaces ofwound W; flexibility to reposition wound closure strip 110 and adjustthe approximation of wound W (i.e., the abutment of the separatedtopical tissue surfaces of the W) before wound closure strip 110 isfully placed on the abutted topical tissue surfaces; ability to handleplacement of wound closure strip 110 without denigrating or minimizingdenigration of the adhesive side of wound closure strip 110;manipulation of wound closure strip 110 is more stable during tissueapproximation as second section 130 provides rigidity for wound closurestrip 110.

It should be understood that the foregoing disclosure and description ofthe present invention are illustrative and explanatory thereof andvarious changes in the size, shape and materials as well as in thedescription of the preferred embodiment may be made without departingfrom the spirit of the invention.

What is claimed is:
 1. A wound closure device having a length A, a widthB, an upper edge, a lower edge, a right-hand edge, and a left-hand edgecomprising: a wound closure strip having a length A, a width F, awound-facing side, a top side, an upper edge and a lower edge, thewound-facing side comprising an adhesive applied over at least a portionof the wound facing side; a release liner assembly detachably adhered tothe wound closure strip by the adhesive, the release liner assemblyconsisting of a first section having a length A and a width E and asecond section having a length A and a width D; wherein the releaseliner assembly extends the full length A of the wound closure device andextends the full width B of the wound closure device, such that therelease liner assembly forms a wound closure strip-free tab, wherein thewound closure strip-free tab has a width of G extending from the loweredge of the wound closure device to the lower edge of the wound closurestrip; wherein the width F of the wound closure strip is greater thanthe width E of the first section by a width H, where H is equal tolength D minus length G; and wherein the first section and the secondsection are separated from each other by a liner cut.
 2. The woundclosure device of claim 1 wherein: the wound closure strip is porous;the length A is from 2 to 20 cm and the width B from 1.7 to 12 cm; thewound closure strip has a width F extending from the upper edge of thewound closure device and where F is from 1.5 to 8 cm; the wound closurestrip-free tab has a width G of 0.2 to 4.0 cm; the first section of therelease liner assembly has a width of E extending from the upper edge ofthe wound closure device and is from 1.5 to 8.0 cm and the secondsection of the release liner assembly has a width D extending from thelower edge of the wound closure device is from 0.2 to 4 cm such that thewidth E of the first section is greater than the width D of the secondsection; and the width B of the device is equal to the width E of thefirst section plus the width D of the second section.
 3. The woundclosure device of claim 1, wherein the wound closure device ismulti-segmented and each segmented device has a length of 1-8 cm.
 4. Thewound closure device of claim 3, wherein the wound closure strip-freetab has a width G of 0 cm.
 5. The wound closure device according to anyone of claims 1-4, wherein the wound closure strip is a mesh.
 6. Thewound closure device according to any one of claims 1-4, wherein theadhesive is provided over the entire wound-facing side of the woundclosure strip.
 7. The wound closure device according to any one of theclaims 1-4, wherein the adhesive is a medical grade adhesive, preferablyselected from acrylic based pressure sensitive adhesives (PSAs), rubberbased pressure sensitive adhesives, silicone pressure sensitiveadhesives and mixtures thereof.
 8. The wound closure device of any oneof the claims 1-4 wherein the wound closure strip includes at least apolymerization initiator or rate modifier.
 9. A kit comprising: (a) thewound closure device of any one of the claims 1-4; and (b) apolymerizable adhesive composition for application over the woundclosure strip after the wound closure strip has been applied to a tissueor wound site.
 10. The kit according to claim 9, wherein thepolymerizable adhesive composition is different to the adhesive appliedto the wound facing side of the wound closure strip.
 11. A method ofclosing a wound having at least a first separated topical tissue surfaceand a second separated topical tissue surface comprising the steps of:a) utilizing the device of any one of the claims 1-4, and in the case ofclaim 3, further separating a segment of the multi-segmented device; b)removing the first section of the release liner assembly to expose aportion of the wound facing side of the wound closure strip whilegrasping the tab of the second section of the release liner assembly; c)adhering a portion of the exposed wound facing side of the wound closurestrip to the at least first separated topical tissue surface and pullingthe tab of the second section of the release liner toward the at leastsecond separated topical tissue surface to form two abutted topicaltissue surfaces and further adhering the exposed wound facing side ofthe wound closure strip to the at least second topical tissue surface;and d) removing the second section of the release liner assembly tofurther expose a wound facing side of the wound closure strip andadhering the further exposed wound closure strip the second topicaltissue surface.
 12. The method of claim 11, further comprising the stepof applying a flowable, polymerizable adhesive over the wound closurestrip.
 13. The method of claim 12, wherein the wound closure stripcomprises a mesh.
 14. The method of claim 13, when the mesh comprisesmaterials selected form the group consisting of polyesters, polyolefinsand polyamides.
 15. The method of claim 14, wherein the flowable,polymerizable adhesive comprises a polymerizable 1,1-disubstitutedethylene monomer.
 16. The method of claim 15, wherein the flowable,polymerizable adhesive comprises an α-cyanoacrylate monomer.
 17. Themethod of claim 16, wherein the mesh further comprises an initiator. 18.The method of claim 17, wherein the initiator is selected from the groupconsisting of benzalkonium and benzyltrialkyl ammonium halides.
 19. Themethod of claim 18 wherein the initiator is benzalkonium chloride. 20.The method of claim 19 wherein the adhesive is an acrylic based pressuresensitive adhesive.